BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3491605 · Received November 27, 2013

    Report

    Report Number
    3007566237-2013-03861
    Event Type
    Injury
    Date Received
    November 27, 2013
    Date of Event
    July 17, 2013
    Report Date
    November 5, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. . IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. THE ARTICLE INCLUDED 24 PATIENTS AFFECTED BY PARKINSON'S DISEASE AND 4 PATIENTS AFFECTED BY PROGRESSIVE SUPRANUCLEAR PALSY. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION IN FOUR PATIENTS. THE THERAPY THE DEVICE WAS USED FOR WAS PROGRESSIVE SUPRANUCLEAR PALSY. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID 3389, LOT# UNKNOWN, PRODUCT TYPE LEAD PRODUCT ID NEU_INS_STIMULATOR. (B)(4).

    Description of Event or Problem · 1

    MAZZONE, P., SPOSATO, S., INSOLA, A., SCARNATI, E. THE CLINICAL EFFECTS OF DEEP BRAIN STIMULATION OF THE PEDUNCULOPONTINE TEGMENTAL NUCLEUS IN MOVEMENT DISORDERS MAY NOT BE RELATED TO THE ANATOMICAL TARGET, LEADS LOCATION, AND SETUP OF ELECTRICAL STIMULATION. NEUROSURGERY. 2013;73(5):894-906. DOI: 10.1227/NEU.0000000000000108. SUMMARY: THE PEDUNCULOPONTINE TEGMENTAL NUCLEUS (PPTG) IS A NOVEL TARGET FOR DEEP BRAIN STIMULATION (DBS) IN MOVEMENT DISORDERS. TO CLARIFY THE RELATIONSHIPS BETWEEN THE INDIVIDUAL ANATOMIC VARIATIONS OF THE BRAINSTEM, THE SITE IN WHICH THE PPTG DBS IS APPLIED, AND THE CLINICAL OUTCOME IN A RELATIVELY LARGE NUMBER OF PATIENTS AFFECTED BY PARKINSON DISEASE OR PROGRESSIVE SUPRANUCLEAR PALSY. MAGNETIC RESONANCE IMAGES HAVE BEEN USED TO EVALUATE BRAINSTEM ANATOMY AND THE RELATIONSHIPS BETWEEN LEAD POSITION AND SPECIFIC BRAINSTEM LANDMARKS. ALL DATA WERE MATCHED ON ATLAS REPRESENTATIONS OF THE PPTG AND WERE CORRELATED WITH UNIFIED PARKINSON DISEASE RATING SCALE III (UPDRS III), SUBITEMS 27 TO 30 OF UPDRS III AND THE HOEHN AND YAHR EVALUATIONS. A HIGH VARIANCE OF BRAINSTEM PARAMETERS WAS EVIDENT, AFFECTING THE RELATIONSHIPS BETWEEN THE POSITION OF THE NUCLEUS AND LEAD CONTACTS. ACCORDING TO THE CONTACTS GIVING THE BEST CLINICAL OUTCOME, PATIENTS COULD BE DISTINGUISHED BETWEEN THOSE WHO REQUIRED THE USE OF 2 ADJACENT CONTACTS AND THOSE WHO REQUIRED STIMULATION THROUGH 2 NONADJACENT CONTACTS. FURTHERMORE, IN THE FORMER GROUP THE TARGET COORDINATES WERE MORE LATERAL AND DEEPER COMPARED WITH THE LATTER GROUP. INDIVIDUAL PPTG-DBS PLANNING IS REQUIRED TO OVERCOME THE INCONSISTENCIES LINKED TO THE HIGH VARIABILITY IN THE BRAINSTEM ANATOMY OF PATIENTS. THE LACK OF CORRELATIONS BETWEEN LEAD POSITION, CONTACT SETUP, AND CLINICAL OUTCOME INDICATE THAT THE BENEFITS OF PPTG DBS MAY NOT BE STRICTLY LINKED TO THE SITE OF STIMULATION WITHIN THE PPTG AREA, AND MAY NOT DEPEND UPON THE NEURONS STILL SURVIVING IN THIS REGION IN PARKINSON DISEASE OR PROGRESSIVE SUPRANUCLEAR PALSY. REPORTED EVENTS: ONE PATIENT EXPERIENCED INTRAOPERATIVE BLEEDING IN THE RIGHT GLOBUS PALLIDUS INTERNUS. AN UNKNOWN NUMBER OF PATIENTS EXPERIENCED PARESTHESIAS IN THE HEMISOMI CONTRALATERAL TO THE IMPLANTED SIDE WHICH WERE FELT BY PATIENTS AS PEDUNCULOPONTINE (PPTG) DEEP BRAIN STIMULATION (DBS) WAS INITIATED OR IN COINCIDENCE WITH MODIFICATIONS OF ELECTRICAL PARAMETERS, IN PARTICULAR, WHEN STIMULATION AMPLITUDE WAS INCREASED. THE REPORTER STATED THAT OVER TIME, THE PERCEPTION OF PARESTHESIAS DECREASED AND FINALLY DISAPPEARED. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618098 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention